To link to the entire object, paste this link in email, IM or documentTo embed the entire object, paste this HTML in websiteTo link to this page, paste this link in email, IM or documentTo embed this page, paste this HTML in website

“Regulatory” due diligence: a survey investigation of best practices in the medical products industry

“REGULATORY” DUE DILIGENCE: A SURVEY INVESTIGATION OF BEST
PRACTICES IN THE MEDICAL PRODUCTS INDUSTRY
by
Susan Bain
__________________________________________________________________
A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE
August 2011
Copyright 2011 Susan Bain

This study analyzed current best practices for regulatory due diligence in the medical products industries. A survey tool was developed to probe the views of industry, and was validated using a focus group of professionals with experience in legal, regulatory and quality due diligence. The survey was completed by 58 regulatory and quality professionals who have been involved in at least one due diligence activity in the medical products area. The responses of respondents were consistent with the predictions of learning theory that emphasize the importance of two dimensions, information gathering and experience accumulation, when developing best practices in regulatory due diligence. However, substantial variability was reported in the experience level of due diligence experts who participated in the due diligence exercises of the respondents. The survey results further identified that current regulatory due diligence practices focus primarily on the performance state of the company as viewed through documentation, but often fail to probe sufficiently other aspects of the organization, including the ethical and organizational state of the company. Results suggest that due diligence audits could be improved by gathering information systematically about such elements as personnel organization, decision-making styles, key personnel to be retained, and evidence of ethical questions or misinformation. These additional elements would provide information that later will be important to going forward with an acquisition and eventually harmonizing the two organizations effectively.

The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the author, as the original true and official version of the work, but does not grant the reader permission to use the work if the desired use is covered by copyright. It is the author, as rights holder, who must provide use permission if such use is covered by copyright. The original signature page accompanying the original submission of the work to the USC Libraries is retained by the USC Libraries and a copy of it may be obtained by authorized requesters contacting the repository e-mail address given.

“REGULATORY” DUE DILIGENCE: A SURVEY INVESTIGATION OF BEST
PRACTICES IN THE MEDICAL PRODUCTS INDUSTRY
by
Susan Bain
__________________________________________________________________
A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE
August 2011
Copyright 2011 Susan Bain